Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

BMC Complementary and Alternative Medicine

Research Article

Wen-jie Tang¹  Yong Gu²  Lin Lu³  Hui-qin Li³  Deng-lei Fu³  Ji-huang Li³  Yan Lin³  Cheng-long Xie³  Ai-ju Liu³  Guo-qing Zheng³  Wen-Wen Wang³ 

[1] Department of Psychology, School of Environmental Science and Public Health, Wenzhou Medical College, 325000, Wenzhou, China;School of Chinese Medicine, University of Hong Kong, Hong Kong, SAR, China;The Center of Neurology and Rehabilitation, The Second Affiliated Hospital of Wenzhou Medical College, 325027, Wenzhou, China;

关键词: Insomnia;    Suanzaoren decoction;    Systematic review;   

DOI  :  10.1186/1472-6882-13-18

 received in 2012-10-22, accepted in 2013-01-03,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundInsomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia.MethodsA systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions.ResultsTwelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information.ConclusionsDespite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed.

【 授权许可】

Unknown   
© Xie et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.